BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Acute Coronary Syndrome Event Detector

    PMA: P150009 · Supplement: S012 · Decision Aug 14, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    4
    Registration Numbers
    4

    Basic Information

    Device Name
    Acute Coronary Syndrome Event Detector
    Trade Name
    Guardian® System
    PMA Number
    P150009
    Supplement Number
    S012
    Device Class
    FDA Class 3
    Product Code
    QBI
    Generic Name
    Acute coronary syndrome event detector
    Medical Specialty
    Unknown
    Advisory Committee
    Cardiovascular
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    August 14, 2024
    Date Received
    February 15, 2024
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    approval of a new programmer for the Guardian System

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QBI Acute Coronary Syndrome Event Detector